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Quality Control For Molecular Immunohematology Tests

BioArray Solutions, Ltd.

The following data is part of a premarket notification filed by Bioarray Solutions, Ltd. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK130050
• 510k Number: BK130050
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Quality Control For Molecular Immunohematology Tests
• Applicant: BioArray Solutions, Ltd. 35 Technology Drive suite 100 Warren, NJ 07059
• Product Code: PFK
• CFR Regulation Number: 864.9650 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Abbrevia
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-09-19
• Decision Date: 2014-05-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10888234102632	BK130050	0
10888234102328	BK130050	0
10888234102298	BK130050	0